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Summary of COVID-19 montelukast studies

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180 patient montelukast late treatment RCT: 92% lower mortality (p=0.01), 81% lower progression (p=0.007), and 15% shorter hospitalization (p=0.04).
RCT 180 hospitalized COVID-19 patients in Turkey showing faster reduction in inflammatory markers, improved pulmonary function, and lower rates of macrophage activation syndrome, respiratory failure and mortality with montelukast treatment (10mg or 20mg daily) in addition to standard care. The higher dose of 20mg daily showed greater improvement in pulmonary function compared to 10mg daily. There was no mortality in the montelukast groups compared to 6.7% mortality with standard care alone.

Jan 2022, J. Medical Virology,,

445 patient montelukast prophylaxis study: 91% lower hospitalization (p=0.02) and 82% fewer cases (p=0.004).
Retrospective 445 elderly patients with severe asthma showing reduced risk of COVID-19 infection with montelukast treatment.

Sep 2020, J. Asthma,,

127 patient montelukast late treatment RCT: 20% shorter hospitalization (p=0.01) and 25% improved recovery (p=0.0006).
RCT 180 hospitalized COVID-19 patients showing improved cough frequency and severity with gabapentin and gabapentin/montelukast compared to dextromethorphan, with the combination being more efficacious. The gabapentin/montelukast group had a significantly greater reduction in cough frequency (measured by the Breathlessness, Cough, and Sputum Scale) compared to the gabapentin alone group. There was no significant difference between the two groups in cough severity reduction measured by Visual Analog Scale.

Jul 2022, The Clinical Respiratory J.,,

68 patient montelukast late treatment RCT: 50% improved recovery (p<0.0001).
RCT 68 post-COVID-19 outpatients showing improvement in cough severity measures with montelukast treatment. The montelukast group had a greater reduction in number of cough paroxysms per day, cough severity visual analog scale, cough severity index, and improved cough quality of life scores compared to the control group. The montelukast group also had a shorter duration of cough.

Sep 2022, The Egyptian J. Bronchology,,

90 patient montelukast late treatment RCT: 67% lower ICU admission (p=0.62), 25% higher progression (p=0.79), and no change in hospital discharge (p=1).
RCT 90 mild to moderate COVID-19 patients showing no significant differences with montelukast treatment.

Nov 2021, Int. J. Basic & Clinical Pharmacology,,

92 patient montelukast late treatment study: 64% lower progression (p=0.09) and 12% shorter hospitalization (p=0.33).
Retrospective 92 hospitalized patients showing lower clinical deterioration with montelukast treatment, without statistical significance in multivariable analysis. The treatment group was older.

Mar 2021, J. Asthma,,

1,250 patient montelukast late treatment RCT: 1% fewer combined hospitalization/ER visits (p=1), 32% lower progression (p=0.29), and 2% improved recovery (p=0.71).
RCT 1,250 outpatients with mild to moderate COVID-19 showing no significant difference in time to sustained recovery with montelukast treatment. There were no deaths and only 2 hospitalizations in each group. Notably, results were better with patients that had mild COVID-19 at baseline compared to moderate/severe cases, and overall efficacy is reduced by poor results with extremely late treatment 9 days after onset, and with patients that had no symptoms at baseline. Authors note the treatment drug was recalled and replaced from another source but do not report why the drug was recalled. Authors describe previous research testing 10mg and 20mg doses, noting that only 20mg showed improved pulmonary function testing, however authors do not indicate why they chose to test the lower dose. It is unclear why authors report all-cause hospitalization and urgent care rather than COVID-19 specific outcomes. Given the low rate of urgent care visits and hospitalization, and the expected baseline..

May 2024, medRxiv,,

616 patient montelukast prophylaxis study: 13% lower hospitalization (p=0.61).
Retrospective 616 COVID-19 patients with asthma in Qatar showing no significant difference in hospitalization risk with montelukast use.

Sep 2023, Qatar Medical J.,,
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